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Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels.
This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.
Postoperative pain is common after video-assisted thoracoscopic surgery (VATS), with pleural irritation caused by chest tube placement being a major contributor. Inadequate pain control may impair respiratory function, delay postoperative recovery, and increase the risk of complications. However, effective and targeted analgesic strategies specifically addressing chest tube-related pain remain limited.
This is a single-center, prospective, randomized, double-blind, placebo-controlled superiority trial designed to evaluate the efficacy and safety of programmed intermittent intrapleural administration of bupivacaine at different concentrations for postoperative analgesia after VATS. A total of 249 patients undergoing VATS will be randomly assigned in a 1:1:1 ratio to receive intrapleural injections of 0.25% bupivacaine, 0.125% bupivacaine, or normal saline. The primary outcome is pain intensity during coughing within 48 hours after surgery. Secondary outcomes include pain intensity at rest, plasma bupivacaine concentrations, quality of postoperative recovery, cumulative opioid consumption, and postoperative inflammatory marker levels.
This study aims to provide evidence to inform analgesic strategies for chest tube-related pain following VATS and to clarify the optimal use and safety profile of intrapleural bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.25% Bupivacaine Intrapleural Analgesia | Experimental | Participants receive programmed intermittent intrapleural administration of 0.25% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated. |
|
| 0.125% Bupivacaine Intrapleural Analgesia | Experimental | Participants receive programmed intermittent intrapleural administration of 0.125% bupivacaine via a chest drainage tube connected to a programmed infusion pump for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated. |
|
| Placebo Intrapleural Analgesia (Normal Saline) | Placebo Comparator | Participants receive programmed intermittent intrapleural administration of normal saline via a chest drainage tube connected to a programmed infusion pump as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery. All participants also receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine 0.125% | Drug | Bupivacaine 0.125% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Pain Intensity During Coughing | Pain intensity during coughing will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated measurements to reflect overall pain burden during the first 48 hours after surgery. Pain assessments will be performed by trained study evaluators. | 1, 2, 6, 12, 24, 36, and 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve of Resting Pain Intensity | Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS; range 0-10). The area under the curve (AUC) of NRS pain scores will be calculated based on repeated assessments to evaluate cumulative resting pain during the first 48 hours after surgery. Assessments will be performed by trained study evaluators. | 1, 2, 6, 12, 24, 36, and 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Bupivacaine Concentration | Plasma concentrations of bupivacaine will be measured to assess systemic exposure following intrapleural administration. Venous blood samples will be collected at predefined time points and analyzed using validated analytical methods. Concentration-time data will be used to characterize the pharmacokinetic profile. | From pre-administration to 48 hours postoperatively |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Leo Li | Contact | 021-18621710790 | 18621710790@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Pulmonary Hospital | Shanghai | China |
De identified individual participant data and related study documents (e.g., study protocol, statistical analysis plan) will be made available upon reasonable request after the completion of the study. Researchers interested in data access may submit a proposal to the principal investigator via email. The proposal should include a detailed research plan and data analysis proposal. Data will be provided following review and approval by the study team. Contact Email: 18621710790@163.com
Supporting documentation will be made available beginning 12 months after publication of the primary study results and will remain available for 5 years thereafter.
De-identified individual participant data that underlie the results reported in the primary publication, as well as the study protocol and statistical analysis plan, will be available to qualified researchers. Requests must be submitted to the principal investigator and will be reviewed on a case-by-case basis. Access will be granted for scientifically sound proposals and subject to approval by the study team and the execution of a data use agreement.
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| Bupivacaine 0.25% | Drug | Bupivacaine 0.25% is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen for postoperative analgesia following video-assisted thoracoscopic surgery. |
|
| Normal Saline | Drug | Normal saline is administered intrapleurally via a chest drainage tube connected to a programmed infusion pump, using a programmed intermittent dosing regimen as a placebo control for postoperative analgesia following video-assisted thoracoscopic surgery. |
|
| Multimodal Analgesia | Other | All participants receive standard multimodal analgesia, including intravenous patient-controlled analgesia, regional nerve block, and rescue analgesic medications as clinically indicated, in addition to the assigned intrapleural intervention. |
|
| Postoperative Opioid Consumption | Total opioid consumption within the first 48 hours after surgery will be recorded and analyzed. | Up to 48 hours postoperatively |
| Quality of Recovery | Postoperative recovery quality will be assessed using the 40-item Quality of Recovery questionnaire (QoR-40), which evaluates multiple domains of postoperative recovery. | Baseline (preoperative), 24 hours, and 48 hours postoperatively |
| Patient Satisfaction With Pain Management | Patient satisfaction with postoperative pain management will be assessed using a 5-point Likert scale ranging from 1 (very dissatisfied) to 5 (very satisfied), reflecting overall satisfaction with pain control. | 48 hours postoperatively |
| Rescue Analgesic Consumption | Total consumption of rescue analgesic medications administered within the first 48 hours after surgery will be recorded and analyzed. | Up to 48 hours postoperatively |
| Postoperative Systemic Inflammatory Response | The postoperative systemic inflammatory response will be assessed as a composite evaluation based on venous blood samples. This assessment will characterize the overall inflammatory response by integrating multiple inflammatory components, including serum cytokine levels (IL-6, IL-8, IL-12, TNF-α), C-reactive protein (CRP), and cellular inflammation indices derived from complete blood count data, including the systemic immune-inflammation index (SII), neutrophil-to-lymphocyte ratio (NLR), and platelet-to-lymphocyte ratio (PLR). | Baseline (preoperative) and 24 hours postoperatively |
| Adverse Events | All adverse events will be recorded from the time of informed consent through hospital discharge. Adverse event severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, and events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA), version 26.1. Serious adverse events will be followed until resolution, stabilization, or up to 30 days after hospital discharge, whichever occurs first. | From informed consent to hospital discharge (serious adverse events followed up to 30 days post-discharge) |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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